Safety and Efficacy of Two Dosages of Inhaled TPI ASM8 Compared to Placebo in Mild to Moderate Asthmatic Patients

Asthma Clinical Trial

Official title:

Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, To Evaluate And Compare The Safety, Tolerability And Efficacy Of Two Dosages Of Inhaled TPI ASM8 Administered For 14 Days In Patients With Mild to Moderate Asthma.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00402948
• Other study ID #: TPI ASM8 -204
• Status: Terminated
• Phase: Phase 2
• First received: November 21, 2006
• Last updated: November 30, 2012
• Start date: February 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2012
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety and tolerability of two dosages of a new drug TPI ASM8 administered by inhalation for 14 days to mild to moderate asthmatic patients, aged between 18-65, non-smokers . The study will also look at the nature and quantity of inflammatory white cells in the lung secretions and in the blood, and some additional inflammation markers.

Description:

See above

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 y. old, non or ex-smokers for > 6 months

• Mild to moderate asthmatic in general good health

• On either low-dose inhaled corticosteroid or steroid naive

• No other asthma medication

• Regular sputum producer

• EOS more than 3% at randomization,

• FEV1 > 70%

Exclusion Criteria:

• Respiratory infection within last 4 weeks

• Any condition that may affect the conduct of the study as per the investigators

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• TPI ASM8
0.25mg, 0.5mg for 14 days, daily dosage
• ASM8
inhalation 0.25mg daily for 14 days

Locations

Country	Name	City	State
Canada	Calgary COPD & Asthma Program	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Firestone Institute for Respiratory Health	Hamilton	Ontario
Canada	McMaster University Hospital	Hamilton	Ontario
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Hopital Sacre Coeur	Montreal	Quebec
Canada	Institut Thoracique de Montreal	Montreal	Quebec
Canada	Hopital Laval- Centre de recherche de Cardiologie et Pneumologie	Quebec
Canada	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	St-Paul's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum eosinophils at Day 1 and Day 14 and safety on Day 14		Prospective	No
Secondary	FEV 1 on Day 1 and Day 14		Prospective	No
Secondary	Rescue Medication (albuterol)for 21 days		Prospective	Yes
Secondary	Gene expression ( mRNA, beta-chain and CCR3 on surface receptors of IL-3, IL-5 and GM-CSF		Prospective	No
Secondary	Blood eosinophils at Day 0 and Day 15		Prospective	No